Trial Information

A Phase 2/3 Multicenter, Randomized, Double Blind Study of Docetaxel (Taxotere) Plus DN-101 or Placebo in Androgen Independent Prostate Cancer (AIPC)

DN-101 is an investigational drug that has not been approved by the U.S. Food and Drug
Administration (FDA). It is a newly formulated pill that contains high amounts of
calcitriol, a naturally occurring hormone and the biologically active form of vitamin D.
Administration of DN-101 results in much higher blood levels of calcitriol than the body can
produce from dietary vitamin D or vitamin D supplements. These higher levels of calcitriol
are associated with anti-cancer effects in laboratory models of human cancer. Laboratory
models also indicate that calcitriol has synergy with many commonly used chemotherapeutic
agents used to treat cancer.

Calcitriol, at very low doses, is currently approved for use in patients with chronic kidney
failure. DN-101 was specifically designed for cancer and contains 30 times the amount of
calcitriol found in the calcitriol pill commercially available today. In order to take an
amount of calcitriol equivalent to 1 DN-101 pill, cancer patients would need to swallow 30
pills of the approved, low dose formulation. DN-101 represents a breakthrough in the use of
calcitriol in the clinic, because it contains high concentrations of calcitriol and makes it
more feasible for patients to stay on regimen.